Clinical trials: Very Preterm Infants, open to volunteers
Very Preterm Maturity of Infant, Very Low Birth Weight Infant
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment
Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification.
- Trial name
- THRIVE (NCT06266455)
- Testing
- Standardized Fortification, Adjustable Fortification
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Children's National Research Institute
Vitamin B-12 Deficiency
THE B-BABIES STUDY: An Observational Study of Group B Vitamins in Preterm Infants
Infancy may be associated with a risk of micronutrient depletion due to the high demands of rapid growth. This is particularly true when preterm birth occurs, as the period before term exhibits the highest rate of bodily growth…
- Trial name
- B-BABIES (NCT07163962)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
Necrotizing Enterocolitis, Intestinal Perforation
Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up
Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall.
- Conditions
- Necrotizing Enterocolitis, Intestinal Perforation, Premature Infant Disease
- Trial name
- NOR-NEC (NCT06757582)
- Where
- Norway
- Volunteers
- 150 people
- Sponsor
- University Hospital of North Norway
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study
Many babies born very preterm (<32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs.
- Trial name
- PrePAP (NCT07251790)
- Testing
- Pre-extubation continuous positive airway pressure
- Where
- 3 sites in Australia
- Volunteers
- 134 people
- Sponsor
- Murdoch Childrens Research Institute
Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease])
Early Surfactant Administration at FiO₂ >0.25 Under NIPPV for RDS in Very Preterm Infants
This multicenter randomized controlled trial investigates whether initiating pulmonary surfactant (PS) at a lower oxygen threshold (FiO₂ >0.25) during nasal intermittent positive pressure ventilation (NIPPV) for very preterm…
- Trial name
- NCT07100652
- Testing
- Threshold FiO₂
- Where
- China
- Volunteers
- 384 people
- Sponsor
- Jiulongpo No.1 People's Hospital
Preterm
Preschool Outcomes of a Previous RCT - ReDiMOM (NCT04540575)
This study will evaluate neurodevelopmental, health, and economic outcomes in preschool children born very preterm that participated in a randomized trial of an economic intervention designed to increase breastmilk feedings while…
- Trial name
- NCT07702357
- Testing
- This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- Rush University Medical Center
Extreme Prematurity (gestational Age Below 29 Weeks)
Oral Feeding Skills of Very Premature Infants
Extremely premature infants, born at a gestational age (GA) of less than 29 weeks, are exposed to numerous complications in the neonatal period (digestive, cardiac, infectious, respiratory, neurological) and in the longer term…
- Trial name
- NUTRIO (NCT06657729)
- Testing
- Succiometry
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Hospices Civils de Lyon
Extra Uterine Growth Restriction, Premature Infant Disease
Does Starting Feeds on the First Day of Life Help Premature Infants Reach Full Volume Feeds Sooner?
Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds.
- Conditions
- Extra Uterine Growth Restriction, Premature Infant Disease, VLBW - Very Low Birth Weight Infant
- Trial name
- NCT06731439
- Testing
- Starting feeds within 6 hours of life, Standard feeding protocol
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- University of Tennessee
Late-Onset Neonatal Sepsis, Extreme Prematurity
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or…
- Conditions
- Late-Onset Neonatal Sepsis, Extreme Prematurity, Neonatal Hypotension
- Trial name
- NCT05347238
- Testing
- Dopamine, Norepinephrine
- Where
- 22 sites in United States, Canada and 3 more
- Volunteers
- 550 people
- Sponsor
- Mount Sinai Hospital, Canada
Low Birthweight Infant, Preterm
Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages
Human milk (HM) is the optimal food source for the nutrition, growth, and development of newborns. The protein fraction of HM plays a crucial role in the healthy development of infants.
- Conditions
- Low Birthweight Infant, Preterm, Very Low Birth Weight Preterms
- Trial name
- PROTEOM-MILK (NCT06787963)
- Where
- 2 sites in Spain
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
Preterm Birth, Blood Transfusion Complication
Blood Warming in Preterm Infants to Decrease Hypothermia
Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia.
- Conditions
- Preterm Birth, Blood Transfusion Complication, Hypothermia
- Trial name
- NCT05170633
- Testing
- Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Very Preterm Birth
High-Dose Intravenous Lipid for Very Preterm or Very Low Birth Weight Infants Effects on Growth
This is a RCT study conducted in Cipto Mangunkusumo Hospital in very preterm infants. The investigators compared early intravena lipid start with 2 gram per body weight and 1 gram per body weight and observed the time to reach…
- Trial name
- NCT06909929
- Testing
- Lipid IV 2 g, lipid IV 1 gram
- Where
- Indonesia
- Volunteers
- 70 people
- Sponsor
- Universitas Indonesia
Prematurity Complications
Gut Permeability and Microbiome in Preterm Infants
NEC, a life-threatening, GI emergency characterized by increased IP, affects approximately 7 to 10% of preterm neonates, and typically occurs within 7 to 14 days of birth with mortality as high as 30-50%.
- Trial name
- NCT07667049
- Testing
- measurement of intestinal permeability
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Maryland, Baltimore
Neonatal Respiratory Distress Syndrome
To Investigate the Effect of Pulmonary Surfactant With Different Inspired Oxygen Concentrations on the Clinical Outcomes of Very Preterm Infants Under Non-invasive Assisted Ventilation
A prospective multicenter randomized controlled study was conducted. Eligible very preterm infants with a gestational age of <32 weeks were enrolled.
- Trial name
- NCT07235345
- Testing
- According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Xu Falin
Very Preterm Infant, Very Low Birthweight
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in…
- Trial name
- LIFT-UP RCT (NCT06765863)
- Testing
- Human Milk Fortifier, Volume targets
- Where
- 4 sites in India
- Volunteers
- 776 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)